lamotrigine

Generic: lamotrigine

Labeler: ajanta pharma usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamotrigine
Generic Name lamotrigine
Labeler ajanta pharma usa inc.
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

lamotrigine 25 mg/1

Manufacturer
Ajanta Pharma USA Inc.

Identifiers & Regulatory

Product NDC 27241-183
Product ID 27241-183_9791ac5c-7be4-4ff8-8de3-21ab21346ca9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213271
Listing Expiration 2026-12-31
Marketing Start 2021-01-19

Pharmacologic Class

Established (EPC)
anti-epileptic agent [epc] mood stabilizer [epc]
Mechanism of Action
organic cation transporter 2 inhibitors [moa] dihydrofolate reductase inhibitors [moa]
Physiologic Effect
decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 27241183
Hyphenated Format 27241-183

Supplemental Identifiers

RxCUI
103968 198430 252478 252479
UPC
0327241184307 0327241186301 0327241183300 0327241185304
UNII
U3H27498KS
NUI
N0000175753 N0000008486 N0000175751 N0000187061 N0000000191

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name lamotrigine (source: ndc)
Generic Name lamotrigine (source: ndc)
Application Number ANDA213271 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (27241-183-30)
source: ndc

Packages (1)

27241-183-30 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (27241-183-30)

Ingredients (1)

lamotrigine (25 mg/1)

Linked Drug Pages (1)

Lamotrigine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9791ac5c-7be4-4ff8-8de3-21ab21346ca9", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000175751", "N0000187061", "N0000000191"], "upc": ["0327241184307", "0327241186301", "0327241183300", "0327241185304"], "unii": ["U3H27498KS"], "rxcui": ["103968", "198430", "252478", "252479"], "spl_set_id": ["9dfb5f87-0150-4c26-a89f-34f1ab389500"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]", "Mood Stabilizer [EPC]"], "pharm_class_moa": ["Organic Cation Transporter 2 Inhibitors [MoA]", "Dihydrofolate Reductase Inhibitors [MoA]"], "manufacturer_name": ["Ajanta Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (27241-183-30)", "package_ndc": "27241-183-30", "marketing_start_date": "20210119"}], "brand_name": "Lamotrigine", "product_id": "27241-183_9791ac5c-7be4-4ff8-8de3-21ab21346ca9", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Dihydrofolate Reductase Inhibitors [MoA]", "Mood Stabilizer [EPC]", "Organic Cation Transporter 2 Inhibitors [MoA]"], "product_ndc": "27241-183", "generic_name": "Lamotrigine", "labeler_name": "Ajanta Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamotrigine", "active_ingredients": [{"name": "LAMOTRIGINE", "strength": "25 mg/1"}], "application_number": "ANDA213271", "marketing_category": "ANDA", "marketing_start_date": "20210119", "listing_expiration_date": "20261231"}